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Evaluation of SCOUT DS in Subjects With Type 2 Diabetes #2 (TCOYD2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VeraLight, Inc.
ClinicalTrials.gov Identifier:
NCT01346046
First received: April 28, 2011
Last updated: December 3, 2012
Last verified: December 2012
History of Changes
  Purpose

The primary objective of the trial is to collect SCOUT DS and Hemoglobin A1c measurements of subjects who have been diagnosed with Type 2 diabetes.


Condition
Diabetes Mellitus, Non-Insulin Dependent

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: An Evaluation of a Noninvasive Diabetes Screening Device in Subjects at the TCOYD Diabetes Conference

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by VeraLight, Inc.:

Primary Outcome Measures:
  • Continuing validation of SCOUT DS algorithm [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Collect SCOUT DS and Hemoglobin A1c measurements of subjects with Type 2 Diabetes


Estimated Enrollment: 264
Study Start Date: May 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Those with Type 2 diabetes
270 subjects with Type 2 diabetes
Non diabetic
30 healthy subjects

Detailed Description:

Previous studies have excluded subjects with Type 2 diabetes. The primary objective of this study is to correct an imbalance in the disease prevalence of the data set used to develop the SCOUT DS diabetes screening algorithm.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Attendees of the Taking Control of Your Diabetes Health Fair, Albuquerque Convention Center

Criteria

Inclusion Criteria:

  • Age greater than or equal to 18 years Self-reported diagnosis of type 2 diabetes No Self-reported diagnosis of type 2 diabetes

Exclusion Criteria:

  • Less than 18 years of age

    • Diagnosed with type 1 diabetes
    • Known to be pregnant (Self Reported)
    • Receiving dialysis or having known renal compromise
    • Scars, tattoos, rashes or other disruption/discoloration on the left volar forearm.
    • Known to have, or at risk for, photosensitivity reactions ( e.g., sensitive to ultraviolet light, or taking medication known to cause photosensitivity)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01346046

Locations
United States, New Mexico
Albuquerque Convention Center
Albuquerque, New Mexico, United States, 87102
Sponsors and Collaborators
VeraLight, Inc.
Investigators
Principal Investigator: Walter Forman, MD Lovelace Scientific Resources
  More Information

No publications provided

Responsible Party: VeraLight, Inc.
ClinicalTrials.gov Identifier: NCT01346046     History of Changes
Other Study ID Numbers: VL-2717
Study First Received: April 28, 2011
Last Updated: December 3, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by VeraLight, Inc.:
Type 2 Diabetes
Adults 18 years and older
Taking Control of Your Diabetes Health Fair

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 19, 2013